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Title 21 Part 892 → Subpart B → §892.2050

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.2050

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.2050

e-CFR data is current as of October 17, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.2050


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.2050   Picture archiving and communications system.

(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

[63 FR 23387, Apr. 29, 1998]


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